Company Situation
The Client is a multinational pharmaceutical company conducting a clinical study in Japan for an oncology product was looking for a local PV service provider who has the experience in handling all Pharmacovigilance activities related to a clinical study in Japan, in compliance with PMDA GVP regulations and ICH E2A and E2B and GVP guidelines.
GRP Solution
GRP PV team in Japan has more than decade of experience in providing pharmacovigilance services in Japan, and was able to provide the following services during the clinical study in Japan: